Sanofi hopes to launch its new cholesterol drug REGN727 in 2015 after beginning patient enrolment in late-stage trials of the drug.
More than 20,000 patients will take part in the study, dubbed ODYSSEY, of the drug which works by blocking the protein PCSK9, responsible for the retention of LDL cholesterol.
Previous trials have seen REGN727 reduce LDL levels by between 40% and 70% without the occurrence of any serious side effects, results that are comparable to the reductions seen in patients taking statins such as AstraZeneca's Crestor and Pfizer's once world-leading Lipitor.
If approved, REGN727 is believed to have the potential to be a multi-billion dollar drug given that it can be prescribed for patients unable to tolerate statins. The drug could also be prescribed to patients unable to reduce their LDL levels to within target with statins.
PCSK9 inhibitors are a developing trend, with various other pharmaceutical companies including Merck and Amgen racing to develop their own variants. Roche's own PCSK9 inhibitor, named RG7652, is due to enter into a final Phase III stage clinical trial next year.
ODYSSEY Steering Committee chair Professor Henry N. Ginsberg said: "Lowering LDL-C remains the primary objective for the management of hypercholesterolemia and has been supported by numerous morbidity and mortality trials."
"Despite the existence of very effective LDL-C lowering therapies, many patients, such as those with heterozygous familial hypercholesterolemia or those with elevated cardiovascular risk, are unable to achieve their LDL-C goals. Sustained PCSK9 blockade represents a potential new option to further reduce LDL-C on top of standard of care statin therapy and help patients achieve their LDL-C goals."
Image: Sanofi's corporate headquarters, located in Paris, France. Image courtesy of Sanofi.